WASHINGTON, Oct. 4 /PRNewswire-USNewswire/ -- The U.S. Food and Drug
Administration today outlined a program aimed at increasing the number and
variety of generic drug products available to consumers and health care
providers. Generic drugs generally cost less than their brand-name
counterparts and competition among generics has been a key factor in
lowering drug prices. The Generic Initiative for Value and Efficiency, or
GIVE, will help the FDA modernize and streamline its generic drug approval
process.

The agency approved or tentatively approved a record of 682 generic
drug products in fiscal year 2007, over 30 percent more than the previous
year.

"To keep pace with the increasing number of generic drug applications,
FDA will implement some changes to the generic drug approval process," said
Gary Buehler, director of FDA's Office of Generic Drugs. "The GIVE plan
outlines ways to maximize the use of our resources so that FDA can review
and approve even more high quality generic drugs during the upcoming fiscal
year than it did in 2007."

As part of the GIVE efforts, FDA is revising the review order for
certain drug applications. For example, first generic products, for which
there are no blocking patents or exclusivity protections on the reference
listed drug, are identified at the time of submission for expedited review.
This will mean that these products, for which there are currently no
generic products on the market, may reach the consumer much faster.

FDA now has about 215 full-time staff working on the review of generic
drug applications. Under GIVE, FDA will hire and train new generic drug
reviewers and focus on enhanced use of electronic programs for handling
drug submissions and internal documents. When possible, resources from
other FDA departments will be engaged in the effort. As well, FDA will
increase its communications with generic drug manufacturers and provide
training on proper application submission to the industry in meetings and
Webcasts.

Generic drugs undergo a rigorous scientific review to ensure that they
are of high quality, safe, and effective. Generic drug manufacturers must
demonstrate that a generic drug has the same dosage form, strength, route
of administration, and conditions of use as the approved brand-name
product. Generic drug manufacturers also must demonstrate bioequivalence,
meaning they show that the drug delivers the same amount of its active
ingredient in the same amount of time as the brand-name counterpart.
Bioequivalence is a critical requirement for concluding that the original
and generic drugs will produce the same therapeutic results.

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